Invokana is a brand name for the diabetes drug canagliflozin and is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Canagliflozin is part of a class of diabetes drugs called sodium glucose-co-transporter 2-inhibitors (SGLT2), designed to help manage diabetes by letting patients expel excess sugar through their urine, which helps lower blood sugar.

The brand name of canagliflozin is sold as Invokana. It’s also available in combination with other medication as Invokamet and Invokamet XR.

Though Invokana treats diabetes, it may have dangerous side effects including an increased risk for developing a flesh-eating infection and the need for amputation of a toe, foot, or leg.

What Side Effects are Associated with Invokana?

Some of the side effects associated with Invokana are manageable, like constipation, nausea, fatigue, vaginal itching, and urinary tract infections, says Rx List. However, other potential Invokana side effects are quite serious.

Invokana may increase a patient’s risk of contracting an infection from flesh-eating bacteria because the drug causes a person to expel excess sugar in the urine. The excess sugar can reportedly stay in and around the genitals, creating an inviting habitat for bacteria.

Additionally, the FDA warns that diabetes patients taking canagliflozin-related drugs may have a higher risk for amputation than other diabetics. These patients include those with a history of neuropathy, foot ulcers, peripheral vascular disease, and patients who have suffered previous amputations, according to EndocrineWeb.

Indeed, over the last five years, the U.S. Food and Drug Administration (FDA) has released a series of six separate Safety Communications about SGLT2 inhibitors, like Invokana, citing infection, amputation, kidney problems, and other serious side effects.

In general, people with diabetes are more likely than others to require amputations because diabetes can damage the nervous system. Because of the nerve damage, a person with diabetes may not know they have injured a foot or leg, for example, and not realize it until the condition has worsened.

Additionally, people with diabetes often have difficulty healing from wounds, increasing the possibility that an injury can become severe. Diabetics’ slow-to-heal nature can open them to infection, which may then necessitate amputation.

Why Does Invokana Increase Risk of Amputation?

Though research indicates a connection between Invokana use and amputations, it does not provide a clear picture of why the two may be linked. Forbes has reported that Invokana may cause a patient’s blood to thicken and pool in the feet.

EndocrineWeb elaborates on this risk, pointing to one researcher’s speculation that a person taking an SGLT2 may become dehydrated because the medication stimulates the kidneys to constantly eliminate urine. This dehydrated state can cause the blood vessels to constrict, reducing blood flow.

According to EndocrineWeb, if foot ulcers occur when blood flow is decreased, a serious bacterial infection could occur, which may then increase the risk of amputation. Since diabetics are already at an elevated risk for foot ulcers, this combination can be quite dangerous.

Diabetics experience a range of issues that could lead to amputation, so it’s hard to screen out what risk is associated with a drug versus risks associated with other things.

EndocrineWeb says the amputations most associated with Invokana are those of the toe and the middle of the foot.

Other Invokana Complications

According to an August 2018 story in USA Today, SGLT2 inhibitors like Invokana, Invokamet, Farxiga, and Jardiance can contribute to the development of a necrotizing or flesh-eating bacteria which specifically attacks the tissues of the perineum. The flesh-eating fasciitis is commonly known as Fournier’s gangrene and, although rare, has a relatively high rate of mortality associated with it—up to 20 percent of those that contract it.

The FDA last year pinpointed these SGLT2 medications and about a dozen others. The drugs are slated to need new warnings to this effect. The conclusion was reached by the drug oversight agency after reviewing 12 patient case studies of Fournier’s gangrene in individuals taking SGLT2 inhibitors over a five- year period.

This rate of diagnosis stood in stark comparison to the half-dozen people who got the disease over a 30-year period after taking different classes of medications to manage diabetes. Contracting necrotizing fasciitis is very serious and almost always requires removing the affected tissue to avoid continued degradation and spread of infection. This requires surgery and is physically as well as psychologically traumatizing to the patient.

USA Today notes that SGLT2 inhibitors like Invokana have only been in use since 2013 when they were first approved for commercial distribution through a doctor’s prescription. While they have been found to be very effective in lowering blood sugar in some people, patients should always be vigilant in looking for potential side effects that could turn problematic.

Genital infections may likely reveal themselves in swelling, redness, or tenderness of the perineal area. These symptoms may or may not be accompanied by a fever. Signs of circulatory problems to the lower extremities might also present with tenderness, redness, or other change of tissue color, or ulcerative wound.

Filing an Invokana Lawsuit

A growing number of people who take Invokana are filing lawsuits after suffering from serious complications, including lower limb amputation. Another major side effect named in these lawsuits is ketoacidosis. Drug companies may be held liable for injuries if it is found that they knew or should have known about the risks, but failed to adequately warn patients and the medical community about the increased risk of amputation or other complications.

Lawsuits allege that manufacturers failed to warn them and the medical community about the risk of canagliflozin side effects. Hundreds of lawsuits have been filed so far.

If you or a loved one have been forced to undergo an amputation because of Invokana or Invokamet, you may be able to file an Invokana lawsuit. While filing an Invokana lawsuit cannot undo the pain and suffering caused an Invokana amputation, it can at the very least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially while dealing with these or other health complications, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.